Beurer GL40 - Page 36

36 Beurer GL40 mmol/L
Note regarding function of the control solution
The control solution contains a fixed concentration of glucose that reacts with the test
strip. A test with the control solution is performed in the same way as a blood test, but the
control solution is used instead of blood. The measurement result from the control solu-
tion must lie within the results range. This results range is printed on every test strip con-
tainer.
Chemical composition
The control solution is a red solution with the following D-glucose level (in percentage shares):
Ingredient
Control solution Control solution
LEVEL 1 LEVEL 2
D-glucose 0.10 % 0.35 %
Non-reactive constituents 99.90 % 99.65 %
Standards
The Beurer GL40 measuring system meets the following European directives and stan-
dards:
IVD (98/79/EC), EN 61010-1, EN 61010-2-101, EN 13640, EN ISO 15197,
MDD (93/42/EC).
Comparison between measured values and laboratory values
Performance characteristics: Accuracy and precision
Whole blood sugar test results were compared with the YSI 2300 laboratory instrument.
For a concentration < 4.2 mmol/L, ≥ 95% lay within +/- 0.8 mmol/L, while for a sugar con-
centration ≥ 4.2 mmol/L, ≥ 95% lay within 20% of the reference values.The CV (variation
coefficient) is < 5 %. The Blood Glucose Measuring device is therefore comparable with a
laboratory system.
For further information on finding out blood sugar content and the different technologies
involved, please refer to appropriate specialist literature.